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The FDA released draft guidelines to help drug firms widen their criteria for determining whether an experimental drug could lead to abuse. Biochemistry and chemistry advances have increased the chance that drugs might have unrecognized potential for abuse, the agency said. The final guidelines will be released after two months of consultation with the public and the drug industry.

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The FDA advised Repros Therapeutics to submit a label that specifies the type of patients who would benefit the most from Androxal, the company's male-infertility drug. The FDA also asked Repros to provide information on the effectiveness of using exogenous testosterone against male infertility.

Medical-device makers should assess the potential reimbursement rates of products at the early stage of the development process, writes John Avellanet, Cerulean Associates' managing director. Evaluating the reimbursement implications early on could help companies to determine the profitability of a product before it reaches the market, Avellanet said.

Graspa, Erytech Pharma's drug candidate for acute lymphoblastic leukemia, received orphan-drug designation from the FDA. The drug is a novel L-asparaginase formulation packed in red blood cells to make it safer. Erytech is considering starting clinical trials of the drug in the U.S., CEO Yann Godfrin said.

Third-party manufacturing issues led the FDA to reject a low-dose contraceptive from Warner Chilcott. The company said it will work with its manufacturing partners and the FDA to address the concern "as rapidly as possible."

Scientists at the Joslin Diabetes Center were able to turn aging blood stem cells of old mice back to a more "youthful" state by introducing certain blood factors taken from young mice. The finding suggests "that the blood system offers a potential therapeutic avenue for age-related stem cell dysfunction," one of the researchers said.